NeoRelief for Muscle Cramping & Restlessness Homeopathic Topical Gel, packaged in a) 4 ml sample packs and b) Net Wt. 2.0 oz (56.7g) bottles, BioLyte Laboratories - Grand Rapids, MI 49534, NDC 58368-002-02
Drug Recall
Official source record
- Recall number
- D-0002-2019
- Event ID
- 81011
- Classification
- Class II
- Status
- Terminated
- Recalling company
- BioLyte Laboratories, LLC
- Reason for recall
- CGMP Deviations: finished product produced with active ingredients recalled by the manufacturer, King Bio Inc., due to water contamination issues that could potentially affect the quality of this product.
- Report date
- October 10, 2018
- Recall initiation date
- August 31, 2018
- Termination date
- August 31, 2020
- Distribution pattern
- Nationwide in the USA
Drug product identifiers
- Manufacturer
- BioLyte Laboratories, LLC
- Brand name
- NEORELIEF FOR MUSCLE CRAMPLING AND RESTLESSNESS
- Generic name
- TOPICAL GEL FOR MUSCLE CRAMPING AND RESTLESSNESS
- Substance names
- ARNICA MONTANA; ARTEMISIA CINA PRE-FLOWERING TOP; ATROPA BELLADONNA ROOT; BLACK COHOSH; CAUSTICUM; FRANGULA CALIFORNICA BARK; HYPERICUM PERFORATUM; JATROPHA CURCAS SEED; LYCOPODIUM CLAVATUM SPORE; POTASSIUM BROMIDE; POTASSIUM CARBONATE; PSEUDOGNAPHALIUM OBTUSIFOLIUM; RUTA GRAVEOLENS FLOWERING TOP; SCUTELLARIA LATERIFLORA; STRYCHNOS IGNATII SEED; TARAXACUM OFFICINALE; VALERIAN; VERATRUM ALBUM ROOT
- Product NDC
- 58368-002
- Package NDC
- 58368-002-02
- Route
- TOPICAL
Where this information comes from
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Frequently asked questions
What does a Class II mean?
FDA classifies this recall as Class II. See how to read an FDA recall record for what each classification level means.
Is this recall still active?
According to the FDA, this recall's status is "Terminated." Always confirm the current status using the source links below, since status can change after Public Health Trace last retrieved this record.
What should I do if I have this medication?
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Official guidance and record verification
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How to interpret this historical record
This record is preserved as published by FDA, as of August 31, 2020.
Status as reported: Terminated.
This page does not imply a current danger or a current consumer instruction -- review the official source for the most current information.
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